Biotechnology Events

Home

Sunesis Pharmaceuticals, Inc.

.

Sunesis Announces Submission of Responses to the EMA Day 120 List of Questions for Marketing Authorization Application for Vosaroxin

SOUTH SAN FRANCISCO, Calif., Oct. 13, 2016 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that it has submitted its responses to European Medicines Agency (EMA) Day 120 List of Questions issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process of the Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older. Sunesis expects to receive the EMA Day 180 List of Outstanding Issues before year-end.

“We are pleased with the comprehensive set of answers and additional analyses that our team has provided in response to the EMA’s Day 120 list of questions,” said Daniel Swisher, President and Chief Executive Officer of Sunesis. “As our regulatory efforts progress to bring vosaroxin to market in Europe as a treatment for relapsed/refractory AML, we are advancing active dialogues with potential pharma collaborators toward the goal of supporting a market launch in 2017. With the clock now restarting, we anticipate being one step closer to that goal.”
More
Source: press release, 10/13/16.

.

Daniel N. Swisher, Jr., CEO and President, gave guidance for the CHMP opinion for Vosaroxin in AML. He stated, "For vosaroxin, we completed the year by achieving one of our top corporate priorities. The submission of our marketing authorization application or MAA in Europe for Vosaroxin as the treatment for relapsed/refractory AML. As we announced in January, the European Medicines Agency validated our MAA and we now expect to see CHMP opinion around year end."
Source: Q4 2015 earnings conference call, 3/10/16.

.

Sunesis Pharmaceuticals Announces European Medicines Agency Validates Marketing Authorization Application for Vosaroxin in AML
SOUTH SAN FRANCISCO, Calif., Jan. 04, 2016 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed refractory acute myeloid leukemia (AML) in patients aged 60 years and older. Validation confirms that the submission is complete and initiates the Centralized Review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Under Centralized Review, the CHMP review period is 210 days, excluding question or opinion response periods, after which the CHMP opinion is reviewed by the European Commission, which usually issues a final decision on EU approval within three months. The MAA submission will be reviewed in the Centralized Procedure, which if authorized, provides a marketing license valid in all 28 EU member states.
“Validation of our vosaroxin MAA begins the EMA review process and brings us another step closer to delivering a new treatment option to patients with relapsed refractory AML,” said Deborah Thomas, Ph.D., Vice President, Regulatory Affairs and Medical Writing. “Following encouraging interactions with the agency last summer, we look forward to progressing to the next stage of the review process, which includes the 120-day questions following the assessment report by the CHMP.”
“We believe European marketing authorization would represent a significant opportunity both commercially and in providing regulatory validation for other geographies around the world,” said Daniel Swisher, Chief Executive Officer of Sunesis. “We look forward to providing more updates in 2016 as we move forward with this regulatory process."
More
Source: press release, 1/04/16. http://ir.sunesis.com/phoenix.zhtml?c=194116&p=irol-newsArticle&ID=21257...

.

Sunesis Pharmaceuticals Announces Submission of a Marketing Authorization Application for Vosaroxin for the Treatment of Acute Myeloid Leukemia in Europe

SOUTH SAN FRANCISCO, Calif., Dec. 8, 2015 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that the company has submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Vosaroxin for the treatment of acute myeloid leukemia in patients aged 60 years and older. The application is subject to validation by the EMA, a process which typically takes one month, before the formal regulatory review of the application begins.
"Submission of an MAA for vosaroxin in relapsed refractory AML was our top priority in 2015. This milestone brings us closer to delivering a new option to a patient population which has seen little improvement in treatment standards in the last 40 years," said Daniel Swisher, Chief Executive Officer of Sunesis. "We believe the European market opportunity is significant, and look forward to providing updates on our progress with the application throughout 2016."
More
Source: press release, 12/08/15. http://ir.sunesis.com/phoenix.zhtml?c=194116&p=irol-newsArticle&ID=21208...

.

Sunesis Announces Anticipated Submission of European Marketing Authorization Application for Vosaroxin in AML Before Year End

Company Also Announces Executive Management Team Changes

Dr. Adam R. Craig to Step Down as Chief Medical Officer Following Transition Period

Jennifer Smith Appointed Vice President, Biometrics

SOUTH SAN FRANCISCO, Calif., Oct. 7, 2015 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that the company intends to submit a Marketing Authorization Application (MAA) for vosaroxin as a treatment for acute myeloid leukemia (AML) with the European Medicines Agency (EMA) by the end of 2015.

The company recently announced that it met separately with the Rapporteur (United Kingdom) and Co-Rapporteur (Netherlands) assigned to provide advice and guidance to the company through the MAA process. Based on these discussions, the company is proceeding with an MAA filing for the indication of relapsed/refractory AML in patients age 60 years and older, a population with the greatest medical need and for whom the greatest benefit was observed in the vosaroxin/cytarabine treatment arm of VALOR, the company's pivotal Phase 3 study of vosaroxin and cytarabine in adult patients with relapsed or refractory AML.

"The filing of an MAA for vosaroxin in Europe by year end is our top corporate priority. As for the U.S., we are refining a plan to find a timely path towards market," said Daniel Swisher, Chief Executive Officer of Sunesis. "With these efforts underway, we also expect to achieve meaningful progress in our kinase inhibitor pipeline, including data presentations at the upcoming November AACR-NCI-EORTC Conference in Boston. Among those being highlighted at the conference is our second generation, differentiated BTK program, SNS-062."

Sunesis also announced today changes to the executive management team. Chief Medical Officer, Adam R. Craig will step down from his role at the end of the year to pursue other opportunities. Dr. Craig will remain available to the company on an advisory basis throughout the regulatory process with the EMA. Also within the Development group, Jennifer A. Smith has been appointed Vice President of Biometrics, where her responsibilities include the statistical design of the company's clinical trials as well as clinical data analyses and presentations, including those supporting ongoing regulatory filings. Dr. Smith joined Sunesis in 2012 from BiPar Sciences where she was Senior Director of Biometrics. Prior to BiPar, she served in similar roles at Geron, Pharmacyclics and Aviron.

Mr. Swisher added: "We thank Adam for his leadership and significant contributions at Sunesis as Chief Medical Officer and look forward to continuing to work with him as a valued advisor in 2016. We have begun a search to complement our experienced internal team with additional clinical development expertise."
More
Source: press release, 10/07/15. http://ir.sunesis.com/phoenix.zhtml?c=194116&p=irol-newsArticle&ID=20951...

.

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Vosaroxin (Voreloxin) AMLOncology HematologicAcute Myelogenous LeukemiaDNA intercalatorDNA replication

Mechanism of action: Vosaroxin is a small molecule and a naphthyridine analogue with antineoplastic activity. Vosaroxin intercalates into DNA in a site-specific manner and blocks the re-ligation process carried out by topoisomerase II during DNA replication. As a result, inhibition of DNA replication, RNA and protein synthesis occurs, followed by cell cycle arrest at G2 phase and induced p53-independent apoptosis. This agent shows a favorable toxicity profile in several aspects: it does not generate reactive oxygen species, as do anthracyclines, reducing the risk of cardiotoxicity; it is not a P-glycoprotein (P-gp) substrate, and thereby evades the common mechanism for multidrug resistance; and it has limited distribution to normal tissues and a more chemically stable molecular structure.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2017-03-24

Results: Pending